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Handle
EUDAMEDClass I (EU MDR)
Ref MHDC-HPRef MHD-YRef RWRef SDH3Ref SDH4Ref SDH1Ref MHDC
Identity
- Trade Name
- Handle EUDAMED
- Device Name
- Handle EUDAMED
- Model / Reference
- MHDC-HP EUDAMEDMHD-Y EUDAMEDRW EUDAMEDSDH3 EUDAMEDSDH4 EUDAMEDSDH1 EUDAMEDMHDC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800099090928 EUDAMED08800099071675 EUDAMED08800099070005 EUDAMED08800099072122 EUDAMED08800099072139 EUDAMED08800099072160 EUDAMED08800099090911 EUDAMED
- Basic UDI-DI
- 88000990HDEXL EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Handle by BioMaterials Korea, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000990HDEXL | Class I | Active |
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Manufacturer
- Manufacturer
- BioMaterials Korea, Inc.
- EUDAMED SRN
- KR-MF-000019882
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (7)
- EUDAMED 8b810853-057c-4330-8a50-e0579292adce 61 fields · synced Jul 29, 2026
- EUDAMED de34ada2-3c27-437b-8cfd-716d7571a198 61 fields · synced May 16, 2026
- EUDAMED 9b6f34b0-c879-40cf-8911-9f7fc2173de8 61 fields · synced May 17, 2026
- EUDAMED 20820e3f-53bc-4a7a-a21f-de2500bbfa0d 61 fields · synced May 17, 2026
- EUDAMED 9d6f22eb-749d-476c-bbe9-02e09b3de86d 61 fields · synced May 18, 2026
- EUDAMED 09b02cea-076b-48e8-8893-03b29999cbe4 61 fields · synced May 18, 2026
- EUDAMED 814c1fc3-0695-4d65-833f-6b9ffbe184c8 61 fields · synced May 18, 2026